ANNEX VI附則
ANNEX VI Information on the minimum donor/recipient data set to be kept as required in Article 9 A. BY TISSUE ESTABLISHMENTS Donor identification Donation identification that will include at least: — Identification of the procurement organisation or Tissue establishment — Unique Donation ID number — Date of procurement — Place of procurement — Type of donation (e.g. single v multi-tissue; autologous v allogenic; living v deceased) Product identification that will include at least: — Identification of the tissue establishment — Type of tissue and cell/product (basic nomenclature) — Pool number (if applicable) — Split number (if applicable) — Expiry date — Tissue/cell status (i.e. quarantined, suitable for use etc.) — Description and origin of the products, processing steps applied, materials and additives coming into contact with tissues and cells and having an effect on their quality and/or safety. — Identification of the facility issuing the final label Human application identification that will include at least: — Date of distribution/disposal — Identification of the clinician or end user/facility B. BY ORGANISATIONS RESPONSIBLE FOR HUMAN APPLICATION (a) Identification of the supplier tissue establishment (b) Identification of the clinician or end user/facility (c) Type of tissues and cells (d) Product identification (e) Identification of the recipient (f) Date of application